Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

Withdrawn

• Conditions: Strabismus; Amblyopia

• Registration Number: NCT03919708
• Lead Sponsor: Rebiscan, Inc.

Brief Summary

The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).

Detailed Description

Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.

The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2020-02-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children who present to the participating clinics
• Provide assent
• Guardian provides informed consent

Exclusion Criteria

• Developmental delay or cognitive deficit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of amblyopia / strabismus	1 single day	Readouts of RBI device will be compared to clinical examination results

Trial Locations

Locations (1)

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States